Self Management of Oral Anticoagulation With VKA TherapyORIONNCT03532724
Clinical Outcomes From Patient Self-management of Antivitamin K Treatment
An observational study of Self Management of Oral Anticoagulation With VKA Therapy, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
ORION is a retrospective, observational, one center study to evaluate the incidence of complications (both thromboembolic and bleedings) in a cohort of patients receiving Vitamin K antagonists (VKA) under a self-management program, since 2002 at the Hospital de la Santa Creu i Sant Pau in Barcelona (Spain) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self Management of Oral Anticoagulation With VKA Therapy
- What is being tested?
- Patient Self-Management of VKA therapy
- Type of treatment
- Medical device
- How many people
- 927 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2017to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from atrial fibrillation, or carrying a cardiac mechanical valve prostheses, or suffering any other cardiac disease with risk of arterial embolism or with a previous venous thromboembolic event with high risk of recurrence, and receiving chronic oral anticoagulation (OA) with any VKA drug, and whom have been trained in our Unit by specialized nurses on self-management of their OA by using a portable coagulometer to weekly test the International Normalized Ratio (INR)
Who may be able to join
- Adult patients (older than 18) under chronic VKA treatment, whom performed patient self-management for any indication of oral anticoagulation.
- Signed informed consent
Who cannot join
- 1. Patients younger than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of the Clinical Outcomes From Patient Self-management of Antivitamin K Treatment at the Hospitald de Sant Pau. ORION Study
ORION is a retrospective, observational, one center study to evaluate the incidence of complications (both thromboembolic and bleedings) in a cohort of patients receiving Vitamin K antagonists (VKA) under a self-management program, since 2002 at the Hospital de la Santa Creu i Sant Pau in Barcelona (Spain)
- Being tested
- Patient Self-Management of VKA therapy
- Keywords
- Patient Self-management, Acenocoumarol, Warfarin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Self-Management of VKA therapyDevice
Trained patients check weekly the INR using a portable coagulometer an decide by themselves the dosis of VKA
What is being measured
The primary outcome is the main question the study is designed to answer.
Thromboembolic events
Any documented embolic stroke, peripheral arterial embolism or venous thromboembolism
Measured: since 1 of july of 2002 to 30th of june of 2018
Major hemorrhagic event
Any documented bleeding event grade 3 or 5 in the Bleeding Assessment Research Consortium (BARC) scale
Measured: since 1 of july of 2002 to 30th of june of 2018
Secondary outcomes (1)
Mortality
Death from any cause
Measured: since 1 of july of 2002 to 30th of june of 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start1 Nov 2017
- Primary completion30 Jul 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self Management of Oral Anticoagulation With VKA TherapyStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 927 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan C Souto, MD, PhD, Principal investigator, Hospital de la Santa creu i Sant Pau - Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532724
- Sponsor's protocol ID
- IIBSP-ORI-2017-45
- Acronym
- ORION
- Status last verified
- Feb 2019
- First submitted
- 8 May 2018
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the Clinical Outcomes From Patient Self-management of Antivitamin K Treatment at the Hospitald de Sant Pau. ORION Study
- ClinicalTrials.gov ID
- NCT03532724
- Acronym / sponsor ID
- ORION / IIBSP-ORI-2017-45
- Keywords
- Patient Self-management, Acenocoumarol, Warfarin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 927 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ORION is a retrospective, observational, one center study to evaluate the incidence of complications (both thromboembolic and bleedings) in a cohort of patients receiving Vitamin K antagonists (VKA) under a self-management program, since 2002 at the Hospital de la Santa Creu i Sant Pau in Barcelona (Spain)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from atrial fibrillation, or carrying a cardiac mechanical valve prostheses, or suffering any other cardiac disease with risk of arterial embolism or with a previous venous thromboembolic event with high risk of recurrence, and receiving chronic oral anticoagulation (OA) with any VKA drug, and whom have been trained in our Unit by specialized nurses on self-management of their OA by using a portable coagulometer to weekly test the International Normalized Ratio (INR)
Key inclusion criteria (2 listed)
- Adult patients (older than 18) under chronic VKA treatment, whom performed patient self-management for any indication of oral anticoagulation.
- Signed informed consent
Key exclusion criteria (1 listed)
- 1. Patients younger than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Self-Management of VKA therapyTrained patients check weekly the INR using a portable coagulometer an decide by themselves the dosis of VKA | Device | – |
Primary outcome
Thromboembolic events
Time frame: since 1 of july of 2002 to 30th of june of 2018
Any documented embolic stroke, peripheral arterial embolism or venous thromboembolism
Major hemorrhagic event
Time frame: since 1 of july of 2002 to 30th of june of 2018
Any documented bleeding event grade 3 or 5 in the Bleeding Assessment Research Consortium (BARC) scale
1 secondary outcome
Mortality
Time frame: since 1 of july of 2002 to 30th of june of 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan C Souto, MD, PhD principal investigator
Hospital de la Santa creu i Sant Pau - Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Self Management of Oral Anticoagulation With VKA Therapy, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thromboembolic events (time frame: since 1 of july of 2002 to 30th of june of 2018). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.